Clinical trial · Interventional
Interferon-gamma or Aldesleukin and Vaccine Therapy in Treating Patients With Multiple Myeloma
Randomized Phase II Trial of Dendritic Cell-Based Idiotype Vaccination With Adjuvant Cytokines for Plateau Phase and Post-Transplant Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Biological therapies, such as interferon-gamma and aldesleukin, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines made from a person's white blood cells may help the body build an effective immune response to kill cancer cells. Giving biological therapy together with vaccine therapy may kill more cancer cells. PURPOSE: This randomized phase II trial is studying how well giving aldesleukin or interferon gamma together with vaccine therapy works in treating patients with multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| flow cytometry | Other | — | UNRESOLVED |
| idiotype-pulsed autologous dendritic cell vaccine APC8020 | Biological | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| recombinant interferon gamma | Biological | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Confirmed response (i.e., clinical or immunological)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma
* Plateau phase multiple myeloma (status post chemotherapy or status post-peripheral blood cell transplantation), meeting the following criteria:
* Serum and urine monoclonal (M) protein values must be stable (\< 20% variation) or must have disappeared
* Serum M protein \< 1 g/dL, and 1 of the following:
* Quantifiable serum M protein
* Adequate serum sample stored in Transfusion Medicine under IRB protocol #698-98
* Urine M protein \< 200 mg/24 hours by electrophoresis on 2 separate occasions for a period of ≥ 4 weeks
* Serum M protein spike ≤ 2.0 g/dL
* No progressive disease after prior autologous stem cell transplantation or chemotherapy
* No non-secretory or light chain myeloma
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 6 months
* WBC ≥ 1,500/μL
* Platelet count ≥ 50,000/μL
* Total bilirubin ≤ 5 times upper limit of normal
* Creatinine ≤ 5.0 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must have adequate venous access for apheresis
* No uncontrolled cardiac disease
* No uncontrolled infection
* No illness or condition which, in the opinion of the investigator, may affect safety of treatment or evaluation of any of the study's endpoints
PRIOR CONCURRENT THERAPY:
* Recovered from all prior therapy
* More than 4 weeks since prior standard-dose chemotherapy, radiotherapy, or immunotherapy
* More than 3 months since prior high-dose chemotherapy with stem cell transplantation
* No concurrent corticosteroidsReferences
Publications (0)
Data not yet available